(37 days)
LOCON-T® Distal Radial Plate System
Not Found
No
The device description focuses solely on the mechanical components (plates and screws) and their physical characteristics. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes.
The device is intended to fix unstable distal radial fractures and repair malunion, which are therapeutic interventions.
No
This device is a surgical implant designed for fixation of distal radial fractures, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of stainless steel, including plates and screws, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- Device Description and Intended Use: The LOCON™ VLS Distal Radius Plate is a surgical implant used for the fixation of bone fractures within the body. It is a physical device that is surgically placed to stabilize a broken bone.
The information provided clearly describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The LOCON™ VLS Distal Radius Plate is intended to be used for fixation of unstable distal radial fractures in which closed reduction is not suitable:
- Joint destruction and/or subluxation visible on x-ray; .
- Failed fracture fixation with or without bone graft; .
- Osteotomy and repair of distal radius malunion with or without bone graft; .
- Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone;
- Volar plates are indicated for use with comminuted articular fractures, shearing fractures . of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator;
- Locking volar plates are indicated for use with volar articular shearing fractures .
Product codes
KTT
Device Description
The LOCON™ VLS Distal Radius Plate System consists of plates, cortical screws, and cancellous screws.
Plates:
- Manufactured from stainless steel .
- Offered in two lengths: Standard and Long .
- Left and right configurations .
- Locking and non-locking screw holes in distal portion .
- Cortical screw holes located in proximal portion .
- Compression slot feature in proximal portion .
- K-wire holes in head and shaft t
- Cupped head with varying arch to accommodate patient's anatomy .
Cortical Screws:
- Manufactured from stainless steel .
- Available with 3.5mm diameter in lengths from 12mm- 20mm .
Cancellous Screws:
- Manufactured from stainless steel .
- Available in two designs: standard and locking .
- Standard screws are available with 2.7mm diameter in lengths from 12 26mm in 2mm . increments
- Locking screws are available with 2.7mm diameter in lengths from 14 26mm in 2mm t increments
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
distal radial fractures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LOCON-T® Distal Radial Plate System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K 042358
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the LOCON™ VLS Distal Radius Plate.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | August 30, 2004 |
| Contact Person: | Jeanine H. Redden |
| Regulatory Affairs Specialist II | |
| Proprietary Name: | LOCONTM VLS Distal Radius Plate |
| Common Name: | Volar Plate |
| Classification Name and Reference: | 21 CFR 888.3030 Plate, Fixation, Bone -- Class II |
| Device Product Code and Panel Code: | 21 CFR 888.3030 Plate, Fixation, Bone -- Class II |
DEVICE INFORMATION
A. INTENDED USE
The LOCON™ VLS Distal Radius Plate is intended to be used for fixation of unstable distal radial fractures in which closed reduction is not suitable:
- Joint destruction and/or subluxation visible on x-ray; .
- Failed fracture fixation with or without bone graft; .
- Osteotomy and repair of distal radius malunion with or without bone graft; .
- Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone;
- Volar plates are indicated for use with comminuted articular fractures, shearing fractures . of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator;
- Locking volar plates are indicated for use with volar articular shearing fractures .
B. DEVICE DESCRIPTION
The LOCON™ VLS Distal Radius Plate System consists of plates, cortical screws, and cancellous screws. The design features of the plates and screw components are summarized ﻨﻮ ・・・・・・・ below:
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Plates
- Manufactured from stainless steel .
- Offered in two lengths: Standard and Long .
- Left and right configurations .
- Locking and non-locking screw holes in distal portion .
- Cortical screw holes located in proximal portion .
- Compression slot feature in proximal portion .
- K-wire holes in head and shaft t
- Cupped head with varying arch to accommodate patient's anatomy .
Cortical Screws
- Manufactured from stainless steel .
- Available with 3.5mm diameter in lengths from 12mm- 20mm .
Cancellous Screws
- Manufactured from stainless steel .
- Available in two designs: standard and locking .
- Standard screws are available with 2.7mm diameter in lengths from 12 26mm in 2mm . increments
- Locking screws are available with 2.7mm diameter in lengths from 14 26mm in 2mm t increments
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The design features, material, and indications for use of the LOCON™M VLS Distal Radius Plate System are substantially equivalent to the LOCON-T® Distal Radial Plate System. The fundamental scientific technology of the modified device has not changed relative to the predicate device. The safety and effectiveness of the LOCON™ VLS Distal Radius Plate is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
UC1 ? ~ 2004
Jeanine H. Redden Regulatory Affairs Specialist II Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessee 38002
Re: K042358 Trade/Device Name: LOCON™ VLS Distal Radius Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: August 30, 2004 Received: September 13, 2004
Dear Ms. Redden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Jeanine H. Redden
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and wyourse FDA finding of substantial equivalence of your device to a legally practed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: LOCON™ VLS Distal Radius Plate
Indications For Use:
The LOCON™ VLS Distal Radius Plate is intended to be used for fixation of unstable distal radial fractures in which closed reduction is not suitable:
- Joint destruction and/or subluxation visible on x-ray; .
- Failed fracture fixation with or without bone graft; .
- Osteotomy and repair of distal radius malunion with or without bone graft; .
- Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone;
- Volar plates are indicated for use with comminuted articular fractures, shearing . fractures of the articular surface, severely comminuted extra-articular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator;
- Locking volar plates are indicated for use with volar articular shearing fractures .
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milburn
of General. Restorative,
and Neurologica. Devices
510(k) Number
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